(Yesterday we highlighted a Reuter’s article that proposed that the lack of funding and drug development for ME/CFS constituted a ‘market failure’. Today we hit back on this market failure with a call for a congressional hearing that asks why the FDA is not, in the face of strong Congressional pressure to approve more drugs for chronic illnesses, giving Ampligen – a drug they now state is safe – conditional approval)

If Ampligen is safe … why has it not received conditional approval?

The following announcement comes from the FDA Treatment Team, a group of people dedicated to securing FDA approval for Ampligen. For readers who are unfamiliar with Ampligen, it is an immune modulating drug that has been used successfully for many years by ME/CFS specialists to treat severely ill patients. The makers of Ampligen have conducted a number of clinical trials proving the safety and efficacy of Ampligen, but, so far, FDA has not approved it.

The team has drafted a letter requesting a congressional hearing on Ampligen. You can support their effort by sending your own letter (see template below).

The team has provided email addresses on their template letter. In addition, it is recommended that you send the letter to your own representatives as well via their web forms. Representatives always pay attention to letters sent by their constituents. You can find your representatives HERE simply by typing in your zip code.
……………………………………………………………………………………..

New Opportunities to Create FDA Action on ME/CFS Treatments

The 21st Century Cures Initiative proposes to accelerate medical breakthroughs …. Ampligen is a breakthrough for some people with ME/CFS which could be quickly available – if the FDA acted.

Currently, Congressmen Fred Upton (R-MI) and Diana DeGette (D-CO) have spearheaded a bipartisan initiative called “21st Century Cures” to increase the pace of medical breakthroughs. This initiative gives us fertile ground to press Congress and the FDA to provide an environment that attracts drug companies to ME/CFS research and for the FDA to give conditional approval of Ampligen. Remember, if we get one drug across the line, many more will follow.

We are asking you to help us continue to push the FDA to foster and approve treatments for ME/CFS. It is important that ME/CFS stay high on the FDA’s agenda. Please cut and paste the following message and send it to the email addresses below.

Subject line: FDA fails to approve drug for ME/CFS – Time for a congressional hearing

In the body of the email:

Recently, Congressmen Fred Upton (R-MI) and Diana DeGette (D-CO) spearheaded a bipartisan initiative called “21st Century Cures” to increase the pace of medical breakthroughs. This initiative provides opportunities to help speed approval for treatments that affect underserved populations – such as those who are severely ill with ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome).

To date, the FDA has failed to approve a drug considered safe for ME/CFS, leaving chronically ill patients to take untested, off-label medications. ME/CFS costs the United States economy approximately $20 billion annually and affects one million Americans. It has left many families in ruins.

The FDA says it will approve drugs with serious adverse side effects that they believe are effective for ME/CFS, but they won’t approve Ampligen, a drug that they acknowledge is safe.

ME/CFS Expert Dr. Charles Lapp, who has treated thousands of ME/CFS patients and has used Ampligen for more than 25 years, said, “Even if Ampligen doesn’t improve a patient, it does no harm.”

The experts have said it works, and the FDA Advisory Committee has said it’s clear that patients are experiencing benefit. More than 700 patients provided testimony at the FDA Advisory Meeting in December 2012 requesting approval of Ampligen, and more than 4,000 signed a petition after FDA denied the approval in February 2013.

In April of 2013 – four months after the FDA denied approval for Ampligen – the FDA admitted they did not have a complete understanding of ME/CFS. We believe that if the FDA had understood the unique needs of ME/CFS patients prior to the Ampligen approval hearing, the drug would have received conditional approval, leading to a functional improvement in many severely ill patients.

The FDA is to be commended for acknowledging the seriousness of ME/CFS. However, more needs to be done. The FDA needs to recognize the special circumstances and desperation of the ME/CFS community and act accordingly by assisting drug companies in bringing their products to market.

A group of patient advocates has demanded a congressional hearing, and I support them. The FDA must live up to its commitment and help those with chronic illnesses. We have a right to treatment; our voices and our experts need to be heard.

Share your pain, make friends, find new treatment options, check out recovery stories and more in the Health Rising ME/CFS, FM and Chronic Pain Forums here

9 Comments

David Downer
on June 13, 2014 at 10:13 pm

I just want to thank Cort Johnson, and the entire Treatment Team for your expertise and all the time and effort that you all put into seeing this threw to bring this before Congress and FDA.I will also write my Congressional Officials and I will also write a letter to Maryland Senator Barry Glassman who is my close personal friend.Senator Barry Glassman has been not only my close personal friend but was a customer of mine for many years before I became bedridden ridden with CFS/ME.He seen me as a very hard working type A personality with an unstoppable drive before becoming bedridden with CFS/ME Oct 1,2008 and damn near lost everything I ever worked for and being a single parent and not being able to provide for my children and not able to pay my bills and mortgage took its toll while waiting for Social security disability and being turned down 3 times and after finally hireing an attorney 3 years later I finally got approved.Anyway,I believe if the government and CDC and FDA all knew the seriousness of this disease and that many of us are in bed or confined to our homes 98 percent of the time and that this disease has the highest rate of suicide out of any other diseases or illnesses that some one might pay attention.I will do my part and I hope and pray we can get everyone put their to do the same.God bless you all.

Cort Johnson
on June 14, 2014 at 11:43 am

Thanks David – what a trial you’ve had! If more people knew yours and others stories I think we would be able to convince them this disorder needs more funding…

I have heard rumors that there is a test to see which ME/CFS patients would respond well to Ampligen. Does anybody Know if this test is available? And where could I get it done?

Cort Johnson
on June 14, 2014 at 11:44 am

All I know is that it’s something that everyone wants to get done and I’ve heard rumors that Hemispherx is working on it but other than that I don’t know.

Terry
on June 14, 2014 at 7:54 am

Letters sent. Thank you.

Cort Johnson
on June 14, 2014 at 11:45 am

Thanks!

CateK
on June 14, 2014 at 4:20 pm

I’m a bit confused – what would I be asking my congressional representative to do? To pressure the FDA on Ampligen? To support “21st Century Cures”? To call for a congressional hearing? If so, where would he find more information?

I want to end the letter with a paragraph requesting some action on his part. What should I ask him to do?

Cort Johnson
on June 14, 2014 at 5:16 pm

Ask him to support a congressional hearing into why Ampligen has not been conditionally approved for ME/CFS.

VBee
on June 19, 2014 at 5:52 pm

Thank you Cort for providing us with the template letter!
I’m a bit slow as far as acting upon important things, but this is letter is now on the TOP of my list of to do things ;).
We absolutely need Ampligen’s approval by the FDA.
I know the history of this drug, it’s full of twists and turns, you can call it a thriller and it makes me wonder why … something has been missing, some very important information.
I really am trying to survive the ME plague to tell the story, a story that I share with all my fellow sufferers.